Connect with us

Technology

Cosmetics Industry Not Prepared for FDA’s New Adverse Events Reporting Requirements

Published

6 months ago

on

Registrar Corp Launches Adverse Events Management Software for FDA MoCRA Compliance

HAMPTON, Va., July 23, 2024 /PRNewswire/ — Registrar Corp, the world’s largest FDA compliance company with 32,000 clients in 190 countries, announced today the launch of Adverse Event Management (AEM) Software.  The first-of-its-kind software enables cosmetics companies to comply with the U.S. Food and Drug Administration’s (FDA) Modernization of Cosmetics Regulation Act (MoCRA).

Cosmetics Companies Are Not Prepared for FDA’s New Adverse Events Requirements

MoCRA has new, stringent requirements for Adverse Events reporting based on the FDA’s medical device and drug adverse events reporting process including:

Display contact information on both the primary and secondary packagingCollect detailed personal and medical information from the consumerInvestigate to determine if the adverse event is a “serious” eventReport “serious” adverse event to the FDA within 15 business daysRecord all health-related adverse events and maintain for up to 6 years

The new regulations will not only impact compliance and regulatory departments but require tight coordination with marketing (product labeling), quality and manufacturing (investigation), legal (consumer liability), and R&D (formulation safety).  

“MoCRA’s Adverse Reporting requirements are incredibly complex and the existing consumer complaints process simply will not work,” said Jaclyn Bellomo, Registrar’s Senior Director of Cosmetic Science and Regulatory Affairs. “The consumer’s medical data needs to be securely collected, processed in real-time, and investigated quickly to meet the 15-day serious adverse reporting requirement.”

Registrar’s Adverse Event Management (AEM) software has been purpose-built for cosmetics companies. The AEM platform securely intakes sensitive consumer medical data, tracks all adverse events for all products globally, transmits information to internal stakeholders, and formats serious adverse events to the FDA MedWatch format for submission to the FDA.

Key Benefits of Registrar’s Adverse Event Management Software:

Consumer-friendly intake:  Consumers can quickly scan a QR code on the label and enter the required data, photos, and documents needed to quickly investigate   Real-Time Tracking & Monitoring: Monitor adverse events globally for every SKU in real time and get the earliest indicator of potential safety or quality issuesProtect Medical/Personal Data: ISO27001-certified security for storage and transmission of medical and personal identifiable information (PII) FDA MedWatch-ready: Serious adverse event reports pre-formatted to the FDA requirements for quick upload and submission

“In the past six months, we have helped over a thousand cosmetics companies get MoCRA ready with product listings, registrations and label reviews,” said Raj Shah, CEO of Registrar Corp. “As FDA enforcement now ramps up and retailers press on brands to get fully MoCRA compliant, we recognized the urgent need to solve their Adverse Events need with our AEM software.”

To learn more about Registrar Corp’s Adverse Event Management Software, visit our website.

About Registrar Corp

Registrar Corp is the world’s largest FDA compliance company with over 32,000 clients in 190 countries.  Our software, services, and training help cosmetics, food, drug and medical device clients comply with complex FDA regulations and keep people healthy and safe.

View original content to download multimedia:https://www.prnewswire.com/news-releases/cosmetics-industry-not-prepared-for-fdas-new-adverse-events-reporting-requirements-302199713.html

SOURCE Registrar Corp

Related Topics:
Continue Reading
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

Technology

TVCMALL Leads Wholesale Innovation for Simplified Online Retail Business Success at CES 2025

Published

2 hours ago

on

January 11, 2025

By

LAS VEGAS, Jan. 11, 2025 /PRNewswire/ — CES 2025, one of the largest tech events globally, concluded with over 4,000 exhibitors showcasing breakthroughs in AI, digital health, and mobility. TVCMALL, a leading one-stop B2B wholesaler, made its second consecutive appearance at the event, delivering comprehensive solutions and introducing a new brand, LEMONDA. With a focus on eco-friendly products and AI-driven accessories, TVCMALL is redefining the wholesale experience for global entrepreneurs.

Revolutionizing Wholesale with AI and Sustainability
TVCMALL is a one-stop platform offering over 1 million SKUs, including mobile accessories, smart tech, and consumer electronics. At CES 2025, the company presented a range of cutting-edge products, from biodegradable phone cases to AI-driven gadgets like Meta Quest 3 headbands, wireless chargers, power banks, and gaming accessories. As part of its innovative approach, TVCMALL launched LEMONDA, a lifestyle brand focused on sustainability. Featuring lightweight, corrosion-resistant resin smartwatch straps and eco-friendly packaging, LEMONDA aligns with the growing demand for green solutions in tech, further cementing TVCMALL’s commitment to a sustainable future.

Comprehensive Solutions for Retailers
TVCMALL simplifies sourcing with an extensive catalog and AI-powered ordering systems, allowing businesses to streamline purchasing and make data-driven decisions. With no minimum order quantity (MOQ) on most products and a flexible dropshipping service, TVCMALL supports businesses with customized solutions tailored to their needs. Whether through personalized packaging or exclusive designs, TVCMALL helps entrepreneurs enhance their brand visibility and stay competitive. The platform also integrates with Amazon and custom APIs for a seamless experience.

Commitment to Quality and Global Growth
TVCMALL is dedicated to helping entrepreneurs succeed in both established and emerging markets. By offering competitive prices, fast delivery, and in-depth market insights, TVCMALL empowers businesses to expand into regions like Europe, Southeast Asia, and Brazil. The company works with trusted partners like Dux Ducis, CaseMe, and Nillkin, ensuring the reliability and quality of its offerings. Additionally, TVCMALL provides value-added services like product photography, factory inspections, and certifications (CE, RoHS), assisting clients with smooth market entry.

“At TVCMALL, our vision is to build a more generous and thriving world,” said Leo Chen, Founder and Chairman of TVCMALL. “CES 2025 is not just an exhibition for us; it’s an opportunity to collaborate, innovate, and inspire a new era of retail and technology.”

For more information, please visit www.tvcmall.com or contact sales@tvcmall.com.

Photo – https://mma.prnewswire.com/media/2593486/TVCMALL_booth_layout_at_CES_2025.jpg

View original content:https://www.prnewswire.co.uk/news-releases/tvcmall-leads-wholesale-innovation-for-simplified-online-retail-business-success-at-ces-2025-302345615.html

Continue Reading

Technology

The green power trading electricity volume in Turfan has surged significantly in 2024

Published

2 hours ago

on

January 11, 2025

By

TURFAN, China, Jan. 11, 2025 /PRNewswire/ — On January 9, 2024, data released by Xinjiang Power Trading Centre Co., Ltd. indicated that the green power trading electricity volume in the Turfan region reached 0.97 billion kWh, representing a remarkable year-on-year increase of up to 14 times. This substantial growth underscores the region’s successful transition towards green energy.

State Grid Turfan Power Supply Company has taken proactive measures to expedite the development of the green power market. The company has facilitated the government’s introduction of a renewable energy consumption action plan, specifying new energy consumption ratios for key energy-consuming entities and establishing a market mechanism with a high proportion of new energy. These efforts have effectively promoted the “new energy participation in all trading varieties of the 24-hour curve” trading model and ensured continuous market opening on working days, thereby better accommodating the fluctuating characteristics of new energy output.

Furthermore, State Grid Turfan Power Supply Company established a green power certificate service station in Gaochang District, providing customers with convenient green power trading services and fostering a green consumption atmosphere throughout society. During the Autonomous Region Tourism Development Conference and the Turfan Grape Festival, the company achieved 100% green power supply and assisted three export-oriented enterprises in achieving low-carbon transformation, thereby enhancing the international influence of their brands.

Looking ahead, State Grid Turfan Power Supply Company will continue to implement measures to expand its “Power Supply + Energy Efficiency Bill” service, guiding society towards more efficient, economical, and environmentally friendly electricity usage, and contributing to the clean and low-carbon transformation of local energy resources.

View original content:https://www.prnewswire.com/apac/news-releases/the-green-power-trading-electricity-volume-in-turfan-has-surged-significantly-in-2024-302348525.html

SOURCE State Grid Turfan Power Supply Company

Continue Reading

Technology

Equipboard Unveils Sleek Redesign to Enhance Music Gear Discovery for Musicians Worldwide

Published

4 hours ago

on

January 11, 2025

By

Redesign Introduces Modern Features, Streamlined Navigation, and Richer Content to Inspire and Support Music Makers Globally

AUSTIN, Texas, Jan. 11, 2025 /PRNewswire-PRWeb/ — Equipboard, the leading online community for musicians and gear enthusiasts, announces the launch of its newly redesigned website. With a modern look, streamlined navigation, and powerful new features, the redesign sets a new standard for connecting artists, producers, and hobbyists with the tools they need to create music.

Since its inception in 2013, Equipboard has grown into the world’s largest database of music gear used by professionals and amateurs alike. The redesign reflects the platform’s commitment to fostering creativity, offering transparent information, and making gear discovery and purchasing easier and more enjoyable for its global user base.

What’s New?

Equipboard’s redesign is more than just a fresh coat of paint. It introduces a host of improvements aimed at elevating the way users explore, share, and connect over their favorite gear:

    Modernized Design: A sleek, responsive layout ensures a seamless experience across all devices, with improved readability and accessibility.    Enhanced Navigation: Faster, more intuitive browsing helps users discover gear, artists, and inspiration effortlessly. Whether searching for a guitarist’s pedalboard or a producer’s go-to synth, the information is now at their fingertips.    Richer Content: Equipboard now features in-depth guides, expert-curated collections, and a revamped artist gear section to inspire and inform users at all levels of their musical journey.    Personalized Experience: Registered users can now enjoy a more tailored interface, saving their favorite gear and creating wishlists for their next creative adventure.    Price Comparisons Across Leading Retailers: Equipboard helps musicians make informed decisions by comparing prices on music gear from top retailers, ensuring they get the best value for their investment.    Community-Focused Features: New tools make it easier for users to contribute to Equipboard’s ever-growing database, ensuring the platform remains the most trusted source for music gear information.

“Equipboard has always been about empowering musicians by connecting them with the tools and insights they need,” said Michael Pierce, Co-Founder. “This redesign reflects our commitment to innovation and community, creating an experience that’s as inspiring as the gear our users discover. From in-depth artist insights to real-time price comparisons, we’re excited to see how these improvements help musicians worldwide make better gear choices and create amazing music.”

About Equipboard

Equipboard is the ultimate online resource for musicians and gear enthusiasts. With a mission to provide transparent, community-driven information about the gear used by artists and professionals, Equipboard has become a trusted destination for millions of music creators. The platform also simplifies the buying process with its innovative price comparison tool, helping users find the best deals from leading retailers. From electric guitars to studio monitors, Equipboard’s extensive database helps users make informed decisions about their music-making journey.

The redesigned Equipboard is now live at https://equipboard.com, offering a fresh look and enhanced tools to support music creators in exploring the gear behind their favorite artists’ sound.

Media Contact

Michael Pierce, Equipboard, 888-888-8888, contact@equipboard.com, https://equipboard.com/

View original content to download multimedia:https://www.prweb.com/releases/equipboard-unveils-sleek-redesign-to-enhance-music-gear-discovery-for-musicians-worldwide-302348502.html

SOURCE Equipboard

Continue Reading

Trending